Kids Flouride Rinse (Sodium Fluoride) Rinse [Winco Foods, Llc] -

KIDS FLOURIDE RINSE (SODIUM FLUORIDE) RINSE [WINCO FOODS, LLC]
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NDC	67091-104-44
Set ID	1cc5d6fb-d14a-49c2-90ac-d9626c55ac02
Category	HUMAN OTC DRUG LABEL
Packager	WinCo Foods, LLC
Generic Name
Product Class
Product Number
Application Number	PART355

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Active ingredient

Sodium fluoride 0.05% (0.02% w/v fluoride ion)
Purpose

Anticavity rinse
Use

aids in the prevention of dental cavities
Warnings

for this product

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.
Directions
- adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste
- remove cap
- pour 10 millilters (10 mL mark on inside of cap); do not fill above 10 mL mark
- vigourously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
- do not swallow the rinse
- do not eat or drink for 30 minutes after rinsing
- instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
- supervise children as necessary until capable of using without supervision
- children under 6 years of age: consult a dentist or doctor
Other information
- store at room temperature
Inactive ingredients

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water
Questions?

Or to report an adverse event call 800-824-1706

Monday - Friday 9am - 4pm MST
Adverse reaction section

"The ADA Council on Scientific Affairs' Acceptance of WinCo Food Anticavity Fluoride Rinse is based on its finding that the product is effective in

helping to prevent and reduce tooth decay, when used as directed."

*This is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Kids Fluoride Rinse.

DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704
principal display panel

SEALED WITH PRINTED NECKAND FOR YOUR PROTECTION

Compare to the active indredient in ACT Anticavity Kids Flouride Rinse

WinCo

FOODS

ANTICAVITY

Fluoride

Rinse

Strong Cavity Protection

Alcohol Free

Helps Strengthen Teeth

ADA

Accepted

American

Dental

Association

Bubble Gum

Flavor

18 FL OZ (532 mL)

INGREDIENTS AND APPEARANCE

KIDS FLOURIDE RINSE
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67091-104
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67091-104-44	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/09/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	02/09/2011

Labeler - WinCo Foods, LLC (056098817)

Registrant - Vi-Jon, LLC (150931459)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		150931459	manufacture(67091-104)

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Medic

KIDS FLOURIDE RINSE (SODIUM FLUORIDE) RINSE [WINCO FOODS, LLC]

Keep out of reach of children.

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